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510(k) K011706

FLEXICAST PRIME by American Dent-All, Inc. — Product Code EJH

K011706 is an FDA 510(k) premarket notification submitted by American Dent-All, Inc. for the device "FLEXICAST PRIME". The FDA issued a decision of Substantially Equivalent on August 6, 2001. The device falls under product code EJH (Alloy, Metal, Base), a Class II device regulated under 21 CFR 872.3710. American Dent-All, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 2001
Date Received
June 4, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alloy, Metal, Base
Device Class
Class II
Regulation Number
872.3710
Review Panel
DE
Submission Type

Other clearances by American Dent-All, Inc.

  • K030161 — SUPERBOND (March 17, 2003)
  • K011705 — SUPREMCAST (August 3, 2001)
  • K003509 — FLEXICAST (January 2, 2001)
  • K001383 — SUPREMCAST V (July 5, 2000)

Other clearances for product code EJH

  • K123929 — BEGOPAL+ (March 14, 2013)
  • K040180 — CONTINUM V (March 4, 2004)
  • K040179 — CONTINUM (March 3, 2004)
  • K033356 — VERASOFT ES (December 30, 2003)
  • K033045 — DREAM BOND, DREAMCAST CHROME, DREAMCAST V, DREAM FLEXICAST, DREAM LITHECAST (December 23, 2003)
  • K032136 — WIROBOND C (September 4, 2003)
  • K031627 — NANO-TICROWN (June 11, 2003)
  • K030632 — PD CASTA-H (May 7, 2003)
  • K030416 — CERACAST-V (April 14, 2003)
  • K030161 — SUPERBOND (March 17, 2003)

FDA data resources